Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

NCT ID: NCT06192979

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-05
• Study Completion Date: 2026-06-30

Brief Summary

Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.

Detailed Description

The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.

Conditions

Amyloidosis; Systemic; AL Amyloidosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapid Response Group

Daratumumab, bortezomib, dexamethasone

Group Type: OTHER

Daratumumab

Intervention Type: DRUG

Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.

Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

Bortezomib

Intervention Type: DRUG

All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.

Dexamethasone

Intervention Type: DRUG

All patients received 20-40 mg oral or intravenous dexamethasone

Non-Rapid Response Group

Daratumumab, venetoclax, dexamethasone

Group Type: OTHER

Daratumumab

Intervention Type: DRUG

Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.

Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

Dexamethasone

Intervention Type: DRUG

All patients received 20-40 mg oral or intravenous dexamethasone

Venetoclax

Intervention Type: DRUG

All patients received venetoclax 400mg daily.

Interventions

Daratumumab

Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.

Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

Intervention Type: DRUG

Bortezomib

All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.

Intervention Type: DRUG

Dexamethasone

All patients received 20-40 mg oral or intravenous dexamethasone

Intervention Type: DRUG

Venetoclax

All patients received venetoclax 400mg daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of systemic AL amyloidosis;

2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;

3. Life expectancy greater than 12 weeks;

4. HGB ≥70g/L;

5. Blood oxygen saturation >90%;

6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;

7. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.

2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;

3. Severe or persistent infection that cannot be effectively controlled;

4. Presence of severe autoimmune diseases or immunodeficiency disease;

5. Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);

6. Patients with HIV infection or syphilis infection;

7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jin Lu, MD

OTHER

Sponsor Role: lead

Responsible Party

Jin Lu, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jin Lu

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jin Lu

Role: CONTACT

jin1lu@sina.com

+8613311491805

Facility Contacts

Yang Liu

Role: primary

pkuphliuyang@bjmu.edu.cn

+8613716926210

Other Identifiers

2023PHB319-001

Identifier Type: -

Identifier Source: org_study_id